Blended Treatment for Alcohol Use Disorder (BLEND-A)

University of Southern Denmark (SDU)

Status: Active, not recruiting

Conditions: Alcohol Use Disorder

Treatments: Device: Blend-A

Study type: Interventional

Funder types: Other

Identifiers

NCT04535258

BLEND-A

Details and patient eligibility

About

Blended Treatment for Alcohol Use Disorder (BLEND-A) is a pragmatic, cluster randomized controlled trial to assess the clinical effectiveness and cost-effectiveness of implementing a blended treatment format that aims to reduce problematic alcohol use. Blended treatment is a treatment format where treatment as usual is offered as a combination of online and face-to-face sessions, integrated into one treatment protocol. The BLEND-A study will evaluate and implement a blended treatment program in routine alcohol addiction treatment. The trial is led by Unit of Clinical Alcohol Research, University of Southern Denmark (UCAR) in collaboration with partners at the Centre for Telepsychiatry in the Region of Southern Denmark (CTP), and Sundhed.dk.

Full description

Background: A major challenge to psychological treatment for Alcohol Use Disorder (AUD) is patient non-compliance. A promising new treatment approach that is hypothesized to increase treatment compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the Internet within the same protocol. While this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for AUD.

Aims: The study described in this protocol aims to examine and evaluate patient compliance with blended AUD treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only.

Methods: The study design is a pragmatic, stepped-wedge cluster randomized controlled trial. The included outpatient institutions (planned number of patients: n=1800) will be randomized in clusters to implement either blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU). Both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. Data on socio-demographics, alcohol consumption, addiction severity, treatment retention, treatment duration and intensity, and type of conclusion of treatment (dropout vs. compliance), will be retrieved from the National Register of Alcohol Treatment (NAB). In addition, all patients will be assessed for alcohol consumption, consequences of drinking and quality of life at treatment entry and six months after treatment conclusion. Data will be analyzed with an Intention-to-treat approach by means of generalized mixed models with random effect for cluster and fixed effect for each step. Also, analyses evaluating cost-effectiveness will be conducted.

Discussion: Blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. Since this study is conducted within an implementation framework it can easily be scaled up, and blended treatment has the potential to become an alternative offer in the majority ofmany outpatient clinics nationwide.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Legal person seeking public alcohol treatment in the participating municipalities.

Exclusion criteria

• None.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,800 participants in 4 patient groups

First-movers

Other group

Description:

The first four alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions.

Treatment:

Device: Blend-A

Second-movers

Other group

Description:

After three months, the next five alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions.

Treatment:

Device: Blend-A

Third-movers

Other group

Description:

After three months, the next five alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions.

Treatment:

Device: Blend-A

Fourth-movers

Other group

Description:

After three months, the last four alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions.

Treatment:

Device: Blend-A